System and method for hyoidplasty

ABSTRACT

Methods and devices are disclosed for manipulating the hyoid bone, such as to treat obstructive sleep apnea. A conformable implant is positioned adjacent a hyoid bone. The spatial orientation of the hyoid bone is manipulated, to affect the configuration of the airway. The implant restrains the hyoid bone in the manipulated configuration. The implant is positioned adjacent to pharyngeal structures to dilate the pharyngeal airway and/or to support the pharyngeal wall against collapse. The implant may be attached to the hyoid bone using a clamp delivery tool that is adapted to releasably engage the implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Application No. 60/636,165 filed on Dec. 15, 2004, thedisclosure of which is incorporated by reference herein in its entirety.In addition, the present application also incorporates by reference inits entirety U.S. application Ser. No. 10/736,457 filed on Dec. 15,2003.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to a system and method for treatingupper airway obstruction, sleep disordered breathing, upper airwayresistance syndrome and snoring.

2. Description of the Related Art

Respiratory disorders during sleep are recognized as a common disorderwith significant clinical consequences. During the various stages ofsleep, the human body exhibits different patterns of brain and muscleactivity. In particular, the REM sleep stage is associated with reducedor irregular ventilatory responses to chemical and mechanical stimuliand a significant degree of muscle inhibition. This muscle inhibitionmay lead to relaxation of certain muscle groups, including but notlimited to muscles that maintain the patency of the upper airways, andcreate a risk of airway obstruction during sleep. Because musclerelaxation narrows the lumen of the airway, greater inspiratory effortmay be required to overcome airway resistance. This increasedinspiratory effort paradoxically increases the degree of airwayresistance and obstruction through a Bernoulli effect on the flaccidpharyngeal walls during REM sleep.

Obstructive Sleep Apnea (OSA) is a sleep disorder that affects up to 2to 4% of the population in the United States. OSA is characterized by anintermittent cessation of airflow in the presence of continuedinspiratory effort. When these obstructive episodes occur, an affectedperson will transiently arouse, regain muscle tone and reopen theairway. Because these arousal episodes typically occur 10 to 60 timesper night, sleep fragmentation occurs which produces excessive daytimesleepiness. Some patients with OSA experience over 100 transient arousalepisodes per hour.

In addition to sleep disruption, OSA may also lead to cardiovascular andpulmonary disease. Apnea episodes of 60 seconds or more have been shownto decrease the partial pressure of oxygen in the lung alveoli by asmuch as 35 to 50 mm Hg. Some studies suggest that increasedcatecholamine release in the body due to the low oxygen saturationcauses increases in systemic arterial blood pressure, which in turncauses left ventricular hypertrophy and eventually left heart failure.OSA is also associated with pulmonary hypertension, which can result inright heart failure.

Radiographic studies have shown that the site of obstruction in OSA isisolated generally to the supralaryngeal airway, but the particular siteof obstruction varies with each person and multiple sites may beinvolved. A small percentage of patients with OSA have obstructions inthe nasopharynx caused by deviated septums or enlarged turbinates. Theseobstructions may be treated with septoplasty or turbinate reductionprocedures, respectively. More commonly, the oropharynx and thehypopharynx are implicated as sites of obstruction in OSA. Some studieshave reported that the occlusion begins with the tongue falling back inan anterior-posterior direction (A-P) to contact with the soft palateand posterior pharyngeal wall, followed by further occlusion of thelower pharyngeal airway in the hypopharynx. This etiology is consistentwith the physical findings associated with OSA, including a large baseof tongue, a large soft palate, shallow palatal arch and a narrowmandibular arch. Other studies, however, have suggested that increasedcompliance of the lateral walls of the pharynx contributes to airwaycollapse. In the hypopharynx, radiographic studies have reported thathypopharyngeal collapse is frequently caused by lateral narrowing of thepharyngeal airway, rather than narrowing in the A-P direction.

OSA is generally diagnosed by performing overnight polysomnography in asleep laboratory. Polysomnography typically includeselectroencephalography to measure the stages of sleep, anelectro-oculogram to measure rapid eye movements, monitoring ofrespiratory effort through intercostal electromyography or piezoelectricbelts, electrocardiograms to monitor for arrhythmias, measurement ofnasal and/or oral airflow and pulse oximetry to measure oxygensaturation of the blood.

Following the diagnosis of OSA, some patients are prescribed weight lossprograms as part of their treatment plan, because of the associationbetween obesity and OSA. Weight loss may reduce the frequency of apneain some patients, but weight loss and other behavioral changes aredifficult to achieve and maintain. Therefore, other modalities have alsobeen used in the treatment of OSA, including pharmaceuticals,non-invasive devices and surgery.

Among the pharmaceutical treatments, respiratory stimulants and drugsthat reduce REM sleep have been tried in OSA. Progesterone, theophyllineand acetozolamide have been used as respiratory stimulants, but eachdrug is associated with significant side effects and their efficacy inOSA is not well studied. Protriptyline, a tricyclic antidepressant thatreduces the amount of REM sleep, has been shown to decrease thefrequency of apnea episodes in severe OSA, but is associated withanti-cholinergic side effects such as impotence, dry mouth, urinaryretention and constipation.

Other modalities are directed at maintaining airway patency duringsleep. Oral appliances aimed at changing the position of the softpalate, jaw or tongue are available, but patient discomfort and lowcompliance have limited their use. Continuous Positive Airway Pressure(CPAP) devices are often used as first-line treatments for OSA. Thesedevices use a sealed mask which produce airflow at pressures of 5 to 15cm of water and act to maintain positive air pressure within thepharyngeal airway and thereby maintain airway patency. Although CPAP iseffective in treating OSA, patient compliance with these devices is lowfor several reasons. Sleeping with a sealed nasal mask is uncomfortablefor patients. Smaller sealed nasal masks may be more comfortable topatients but are ineffective in patients who sleep with their mouthsopen, as the air pressure will enter the nasopharynx and then exit theoropharynx. CPAP also causes dry nasal passages and congestion.

Surgical treatments for OSA avoid issues with patient compliance and areuseful for patients who fail conservative treatment. One surgery usedfor OSA is uvulopalatopharyngoplasty (UPPP). UPPP attempts to improveairway patency in the oropharynx by eliminating the structures thatcontact the tongue during sleep. This surgery involves removal of theuvula and a portion of the soft palate, along with the tonsils andportions of the tonsillar pillars. Although snoring is reduced in amajority of patients who undergo UPPP, the percentage of patients whoexperience reduced frequency of apnea episodes or improved oxygensaturation is substantially lower. Postoperatively, many patients thathave undergone UPPP continue to exhibit oropharyngeal obstruction orconcomitant hypopharyngeal obstruction. Nonresponders often havephysical findings of a large base of tongue, an omega-shaped epiglottisand redundant aryepiglottic folds. UPPP is not a treatment directed atthese structures. UPPP also exposes patients to the risks of generalanesthesia and postoperative swelling of the airway that will require atracheostomy. Excessive tissue removal may also cause veto-pharyngealinsufficiency where food and liquids enter into the nasopharynx duringswallowing.

Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar procedureto UPPP that uses a CO2 laser to remove the uvula and portions of thesoft palate, but the tonsils and the lateral pharyngeal walls arc notremoved.

For patients who fail UPPP or LAUP, other surgical treatments areavailable but these surgeries entail significantly higher risks ofmorbidity and mortality. In genioglossal advancement with hyoid myotomy(GAHM), an antero-inferior portion of the mandible, which includes theattachment point of the tongue musculature, is repositioned forward andin theory will pull the tongue forward and increase airway diameter. Themuscles attached to the inferior hyoid bone are severed to allow thehyoid bone to move superiorly and anteriorly. Repositioning of the hyoidbone expands the retrolingual airspace by advancing the epiglottis andtongue base anteriorly. The hyoid bone is held in its new position byattaching to the mandible using fascia. Variants of this procedureattach the hyoid bone inferiorly to the thyroid cartilage.

A laser midline glossectomy (LMG) has also been tried in some patientswho have failed UPPP and who exhibit hypopharyngeal collapse onradiographic studies. In this surgery, a laser is used to resect themidline portion of the base of the tongue. This involves significantmorbidity and has shown only limited effectiveness.

In some patients with craniofacial abnormalities that include a recedingmandible, mandibular or maxillomandibular advancement surgeries may beindicated for treatment of OSA. These patients are predisposed to OSAbecause the posterior mandible position produces posterior tonguedisplacement that causes airway obstruction. In a mandibular advancementprocedure, the mandible is cut bilaterally posterior to the last molarand advanced forward approximately 10 to 14 mm. Bone grafts are used tobridge the bone gap and the newly positioned mandible is wire fixated tothe maxilla until healing occurs. Mandibular advancement may be combinedwith a Le Fort I maxillary osteotomy procedure to correct associateddental or facial abnormalities. These procedures have a high morbidityand are indicated only in refractory cases of OSA.

Experimental procedures described in the clinical literature for OSAinclude the volumetric radiofrequency tissue ablation and hyoidplasty,where the hyoid bone is cut into several segments and attached to abrace that widens the angle of the U-shaped hyoid bone. The latterprocedure has been used in dogs to increase the pharyngeal airway lumenat the level of the hyoid bone. The canine hyoid bone, however, isunlike a human hyoid bone because the canine hyoid bone comprises nineseparate and jointed bones, while the human hyoid bone comprises fivebones that arc typically fused together.

Notwithstanding the foregoing, there remains a need for improved methodsand devices for treating obstructive sleep apnea.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the presentinvention, a method of performing hyoidplasty. The method comprises thesteps of accessing a hyoid bone, having a first and a second greaterhorn spaced apart by a first distance. The space between the first andsecond greater horns is increased to a second distance, and the firstand second greater horns are restrained at the second distance. Thehyoid bone accessed may be a human hyoid bone.

In one implementation of the invention, the accessing step isaccomplished in a minimally invasive procedure.

The increasing the space step may comprise flexing the hyoid bone,separating the hyoid bone into at least two components, or separatingthe hyoid bone into at least three components. The second distance maybe at least about 110%, in some procedures at least about 120% and inother procedures at least about 130% of the first distance. Therestraining step may comprise securing the hyoid bone to a hyoid bonesupport. Alternatively, the restraining step may occur without attachingan implant to the hyoid bone.

In accordance with another aspect of the present invention, there isprovided an implant for attachment to a hyoid bone. The implantcomprises an implant body, having a first attachment zone configured forattachment to a first portion of a hyoid bone. The implant body includesa second attachment zone, configured for attachment to a second portionof a hyoid bone. A connection is provided between the first and secondattachment zones, which allows movement of the first and secondattachment zones with respect to each other. A lock may be carried bythe body, for fixing the relationship between the^(e) first and secondattachment zones.

The connection may comprise a flexible portion of the body.Alternatively, the connection may comprise a hinge, pivot or a flexibleelement carried by the body. The lock may comprise a threaded shaft, orany of a variety of interference fit structures. The connection may alsocomprise a pivot joint. The first attachment zone optionally comprises adeformable structure adapted to conform to the hyoid bone. The lock maycomprise one or more fasteners.

In accordance with a further aspect of the present invention, there isprovided a method of treating a patient. The method comprises the stepsof providing a hyoid bone support, having a first arm and a second armwhich are transformable from a moveable relationship with respect toeach other to a fixed relationship with respect to each other. The firstarm is attached to a first part of a hyoid bone. The second arm isattached to a second part of a hyoid bone. The configuration of thehyoid bone is changed, and the support is secured in the fixedrelationship.

The changing the configuration step may comprise increasing a lateraldistance between the first and second parts of the hyoid bone, and/orincreasing an anterior-posterior distance between the first and secondparts of the hyoid bone. Increasing the anterior-posterior distance maycomprise the insertion of at least one spacer between the first andsecond parts, and/or attaching a brace to the first and second arms ofthe hyoid bone support to expand the distance between the first arm andthe second arms. The changing the configuration step may be accomplishedeither before or after the attaching steps.

In one implementation of the invention, the attaching step comprisesattaching the first and second arms to the hyoid bone using screws.Alternatively, the attaching step may comprise using one or more boneclips, sutures, adhesives, or other attachment techniques known in theart.

The hyoid bone also comprises an arc length along the bone, between theends of the first and second greater horns. Any of the foregoing methodsmay additionally comprise the step of increasing the arc length of thehyoid bone, such as by separating the hyoid bone into two or morecomponent parts and providing a space between the adjacent parts. Thebone components may then be secured with respect to each other.

In accordance with another embodiment of the present invention, there isprovided a method of treating a patient. The method comprisesidentifying the hyoid bone, having a first and second greater horns anda midpoint on the hyoid bone halfway between the ends of the first andsecond greater horns such that a first line extending from the midpointthrough an end of the first greater horn and a second line extendingfrom the midpoint through an end of the second greater horn define anangle. The angle is changed and the hyoid bone is secured to retain thechanged angle. Access to the hyoid bone may be accomplished in aminimally invasive procedure.

In accordance with another embodiment of the invention, there isprovided still another method for treating a patient. The methodcomprises the steps of providing a pharyngeal support, having a firstarm and a second arm which are transformable from a moveablerelationship with respect to each other to a fixed relationship withrespect to each other. The first arm is positioned with respect to afirst part of the pharynx and the second part is positioned with respectto another part of the pharynx. The configuration of the pharynx ischanged and the support is secured in the fixed relationship.

The positioning step may comprise forming an interference fit in afascial plane in proximity to a pharyngeal wall or between twopharyngeal muscles. The pharyngeal muscles may be a suprahyoid muscleand/or an infrahyoid muscle.

In one implementation of the invention, the method further comprisesattaching at least one arm of the pharyngeal support to a part of thepharynx. The attaching step may be performed using a tissue anchor,hook, suture, clip or adhesive. The attaching step may occur before orafter the changing the configuration step:

There is provided in accordance with another aspect of the presentinvention an implant for positioning in a pharyngeal structure,comprising an implant body; a first tissue contact zone configured forcontacting a first portion of a pharyngeal structure, a second tissuecontact zone configured for contacting a second portion of a pharyngealstructure, a connection between the first and second contact zones whichallows movement of the first and second contact zones with respect toeach other and a lock carried by the body for fixing the relationshipbetween the first and second contact zones. The portion of a pharyngealstructure may comprise a suprahyoid muscle, an infrahyoid muscle or ahyoid bone.

In another embodiment of the invention, a hyoid bone brace comprising afirst attachment structure for attaching to a first portion of the hyoidbone, and a second attachment structure for attaching to a secondportion of the hyoid bone, wherein the first attachment structure andsecond attachment structure are joined by a joint. The first attachmentstructure may comprise a first conformable bone contact structure andmay also further comprise a complementary first conformable bone contactstructure. The second attachment structure may comprise a secondconformable bone contact structure and may also further comprise acomplementary second conformable bone contact structure. The firstattachment structure may also comprise a clamping structure. Theclamping structure may comprise a first conformable bone contactstructure. The joint may be a sliding, pivot or mechanical interfitjoint. The joint may be fixable.

In another embodiment, a method for performing hyoidplasty is provided,comprising the steps of providing hyoidplasty implant, the implantcomprising a first arm, a second arm; contacting the first arm andsecond arm to a hyoid bone; and increasing the contact of the first armto the hyoid bone by deforming the implant. The method may furthercomprise increasing the contact of the second arm to the hyoid bone bydeforming the implant, and may also further comprise fixing the relativeposition between the first arm and the second arm. In anotherembodiment, the method may comprise joining the first arm and the secondarm, and optionally comprise fixing the relative position between thefirst arm and the second arm.

Further features and advantages of the present invention will becomeapparent to those of skill in the art in view of the disclosure herein,when considered together with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The structure and method of using the invention will be betterunderstood with the following detailed description of embodiments of theinvention, along with the accompanying illustrations, in which:

FIG. 1 is a sagittal view of the pharynx.

FIGS. 2A and 2B depict the hyoid bone with respect to the thyroid andcricoid cartilage in a lateral and anterior view, respectively.

FIG. 2C is a superior view of the hyoid bone.

FIG. 3 illustrates the musculature attached to the hyoid bone in alateral view.

FIG. 4 shows an anterior view of the musculature attached to the hyoidbone. The right side depicts the superficial musculature and the leftside shows the deep musculature.

FIGS. 5A and 5B are superior and lateral views of one embodiment of theinvention, with the hyoid brace in a folded position. FIGS. 5C and 5Dshow the brace in an unfolded position.

FIGS. 6A through 6C represent at least one embodiment of the invention,utilizing a clevis pin pivot joint and a combination of bone screws andhooks to attach the hyoid brace to the hyoid bone.

FIGS. 7A through 7D represent at least one embodiment of the invention,using various pivot joints.

FIG. 8A depicts a system suitable for practicing at least one embodimentof the invention, comprising two brace arms and a bridge.

FIG. 8B shows the brace arms attached to a hyoid bone and FIG. 8Cillustrates the attachment of the bridge.

FIG. 9 depicts another embodiment of the invention with two brace armsand an adjustable width bridge.

FIG. 10 illustrates another embodiment of the invention with selectablebridge sizes.

FIG. 11A represents another embodiment of the invention with four bracearms.

FIG. 11B shows the attachment of the four brace arms to multiple hyoidbone segments and FIG. 11C shows the widening of the hyoid bonesegments.

FIGS. 12A through 12D represent various embodiments of attaching thehyoid brace to the hyoid bone.

FIGS. 13A and 13B are anterior and superior views of one embodiment ofthe configuration lock of the hyoid brace where the locking interface isembedded within the hyoid brace.

FIGS. 14A and 14B are anterior and superior views of another embodimentof the configuration lock of the hyoid brace where the configurationlocking interface protrudes from the hyoid brace.

FIGS. 15A and 15B arc lateral and end views of one embodiment of theinvention with a locking member having a rotational interface.

FIG. 15C shows the tool that inserts into the rotational interface.

FIGS. 15D and 15E are anterior and superior views of one embodiment ofthe invention utilizing the locking member with the rotationalinterface.

FIGS. 16A and 16B depict embodiments of the invention with a grippablesurface on the locking member.

FIGS. 17A and 17B represent embodiments of the invention shows therelative position of the pivot joint and the configuration lock.

FIGS. 18A and 18B illustrate other embodiments of the configuration lockusing semi-flexible locking members.

FIG. 18C is a cross sectional view of the locking interface for thelocking member of FIG. 18B.

FIGS. 19A and 19B depict embodiments of the invention with tiltablelocking interfaces.

FIGS. 20A and 20B show embodiments of the invention with partiallyflexible brace arms and a wire-based configuration lock.

FIGS. 21A and 21B illustrate one embodiment of configuration lockutilizing suture knots.

FIGS. 22A and 22B represent one embodiment of invention using a tensionspring.

FIG. 23A shows the anatomical position of the hyoid bone relative to thethyroid cartilage and other landmarks of the head and neck.

FIGS. 23B through 23G represents at least one embodiment of theinvention comprising an attachment of separate brace arms to the hyoidbone, joining the two brace arms and generally fixing their relativespatial position with suture or surgical wire.

FIGS. 24A through 24C depict various embodiments of spacers that may beused with the invention.

FIG. 24D is an oblique view of the adjustable spacer in FIG. 23C.

FIGS. 25A and 25B are some embodiments of the delivery tool capable ofminimally invasive insertion.

FIG. 26A depicts one embodiment of an outer sheath.

FIG. 26B depicts one embodiment of the distal end of the delivery toolcapable of inserting a brace arm next to the hyoid bone in a minimallyinvasive procedure.

FIG. 27A depicts one embodiment of the hyoidplasty implant in anisometric view.

FIG. 27B depicts the implant of FIG. 27A separted into two arms.

FIGS. 27C and 27D depict superior elevational views corresponding to theimplants shown in FIGS. 27A and 27B.

FIGS. 28A and 28B are cross sectional views of one embodiment of thehyoidplasty device positioned about a hyoid bone and after attachment tothe hyoid bone, respectively.

FIGS. 29A and 29B illustrate another embodiment of the invention with afemale interfit member and a male interfit member.

FIGS. 30A and 30B illustrate another embodiment of the invention with afemale interfit member and a male interfit member.

FIG. 30C depicts an alternate male interfit member.

FIG. 31 is a front elevational view of the implant of FIGS. 27A through27D.

FIGS. 32A and 32B are lateral and isometric elevational views of oneembodiment of the invention comprising a hyoid brace delivery tool.

FIGS. 32C and 32D are detailed lateral and isometric elevational viewsof the distal end of the hyoid brace delivery tool.

FIG. 33 depicts another embodiment of the invention comprising a triggerhandle position lock assembly.

FIG. 34A and 34B illustrate another embodiment of the inventioncomprising complementary mechanical position lock members.

FIG. 35A represents an alternative embodiment of the inventioncomprising longitudinally moving clamp members.

FIG. 35B represents still another alternative embodiment of theinvention comprising longitudinally moving clamp members.

FIGS. 36A and 36B depicts one embodiment of a brace retaining structurecomprising a clasp mechanism.

FIGS. 37A and 37B depict another embodiment of a brace retainingstructure comprising a toe grip assembly.

FIGS. 38A and 38B illustrate one embodiment of an alignment structurelocated on a clamp member.

FIG. 39A is an exploded view of one embodiment of a drill guide assemblyand distal end of a clamp member.

FIG. 39B and 39C are frontal and lateral views of the drill guideassembly of FIG. 39A.

FIG. 40 is an isometric elevational view of an alternate embodiment of adrill guide assembly.

FIG. 41A illustrates one embodiment of the invention comprising a drillstop assembly.

FIGS. 41B to 41D depict the drill stop assembly attached to actuator ofthe the brace retaining structure in FIG. 37A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A. Anatomy of thePharynx

FIG. 1 is a sagittal view of the structures that comprise the pharyngealairway and may be involved in obstructive sleep apnea. The pharynx isdivided, from superior to inferior, into the nasopharynx 1, theoropharynx 2 and the hypopharynx 3. The nasopharynx 1 is less commonsource of obstruction in OSA. The nasopharynx is the portion of thepharynx above the soft palate 4. In the nasopharynx, a deviated nasalseptum 5 or enlarged nasal turbinates 6 may occasionally contribute toupper airway resistance or blockage. Only rarely, a nasal mass, such asa polyp, cyst or tumor may be a source of obstruction.

The oropharynx 2 comprises structures from the soft palate 4 to theupper border of the epiglottis 7 and includes the hard palate 8, tongue9, tonsils 10, palatoglossal arch 11, the posterior pharyngeal wall 12and the mandible 13. The mandible typically has a bone thickness ofabout 5 mm to about 10 mm anteriorly with similar thicknesses laterally.An obstruction in the oropharynx 2 may result when the tongue 9 isdisplaced posteriorly during sleep as a consequence of reduced muscleactivity during REM sleep. The displaced tongue 9 may push the softpalate 4 posteriorly and may seal off the nasopharynx 1 from theoropharynx 2. The tongue 9 may also contact the posterior pharyngealwall 12, which causes further airway obstruction.

The hypopharynx 3 comprises the region from the upper border of theepiglottis 7 to the inferior border of the cricoid cartilage 14. Thehypopharynx 3 further comprises the hyoid bone 15, a U-shaped, freefloating bone that does not articulate with any other bone. The hyoidbone 15 is attached to surrounding structures by various muscles andconnective tissues. The hyoid bone 15 lies inferior to the tongue 9 andsuperior to the thyroid cartilage 16. A thyrohyoid membrane 17 and athyrohyoid muscle 18 attaches to the inferior border of the hyoid 15 andthe superior border of the thyroid cartilage 16. The epiglottis 7 isinfero-posterior to the hyoid bone 15 and attaches to the hyoid bone bya median hyoepiglottic ligament 19. The hyoid bone attaches anteriorlyto the infero-posterior aspect of the mandible 13 by the geniohyoidmuscle 20.

The position of the hyoid bone relative to the thyroid and cricoidcartilage is shown in FIGS. 2A and 2B. The hyoid bone is a U-shaped bonecomprising a body 21, two lesser horns 22 and two greater horns 23, as ashown in a superior view in FIG. 2C. As shown in FIG. 3, at thepharyngeal level of the hyoid bone, the hyoid bone forms the anteriorportion of the pharynx while a pair of middle constrictor muscles 24forms the remaining portions of the airway. The muscle fibers of themiddle constrictor muscles 24 originate from the greater 23 and lesserhorns 22 of the hyoid bone 15 and fan out posteriorly, inferiorly andsuperiorly to the posterior midline pharynx (not shown). A stylohyoidligament 25 attaches from the cranium to the hyoid bone. FIG. 4illustrates the attachments of the extrinsic muscles of the larynx. Theleft side of the illustration in FIG. 4 depicts the anatomy of thesuperficial musculature and the right side depicts the deepermusculature. The posterior belly 26 of the digastric muscle originatesfrom the mastoid process 27 and attaches to the lesser horn 22 of thehyoid bone 15 as a tendon and then attaches as an anterior belly 28 tothe mandible 13. The stylohyoid muscle 29 originates from the styloidprocess (not shown) of the cranium and then splits into two portionsupon inserting adjacent to the lesser horn of the hyoid bone 15 to allowthe digastric muscle to pass anteriorly. Deep to the digastric 26, 28and stylohyoid 29 muscles are the hyoglossus muscles 30, attaching tothe superior surfaces of the greater horns 23 of the hyoid bone 15 andinserting into the lateral areas of the tongue 9. Further deep is themylohyoid muscle 31, a sheet of muscle that courses between the hyoidbone 15 and the lateral interior sides of the mandible 13, forming aportion of the musculature of the floor of the mouth along with thegeniohyoid muscle 20. These muscles move the hyoid bone 15 and tongue 9superiorly and anteriorly, and are involved in the act of swallowing.Overlying most of the antero-lateral neck is the platysma muscle (notshown) that originates over the upper anterior chest and inserts overthe anterior surfaces of the mandible 13.

The omohyoid muscles 32 are the most lateral of the muscles that attachto the inferior surface of the hyoid bone 15. The omohyoid muscles 32also have two bellies. The inferior belly 33 attaches to the scapula andthe superior belly 34 attaches to the inferior body of the hyoid bone15. The two bellies 33, 34 are joined by a tendon 32 that is continuouswith fascia along the medial ends of the clavicles 46. Also attached tothe inferior surfaces of the hyoid bone are the sternohyoid muscles 35that originate at the manubrium 36 of the sternum and the thyrohyoid 18muscles that originate along the antero-inferior border of the thyroidcartilage 16. The inferior muscles of the hyoid bone act to increase theluminal opening of the pharynx at the level of the hyoid bone 15.

B. Hyoid Brace

In one embodiment shown in FIGS. 5A and 5B, the hyoid brace orhyoidplasty implant comprises at least two brace arms 39, each with alateral end 40, a medial end 41, an inner surface 42 capable of facingthe hyoid bone or portion thereof, an outer surface 43, a superiorsurface 44 and an inferior surface 45. Hyoidplasty, as used herein,shall be given its ordinary meaning, and shall also include anyalteration in the configuration or location of the hyoid bone or bonesegments, including changes in angulation, anterior-posteriordimensions, lateral wall dimensions and/or removal of at least a portionof the hyoid bone. In one embodiment, the hyoid brace also has a flexpoint such as a pivot joint that joins the two brace arms 39. The pivotjoint provides the hyoid brace with a folded position and an unfoldedposition. In the folded position, shown in FIG. 5B, the two lateral ends40 of the hyoid brace are in closer proximity with one another. In theunfolded position, shown in FIG. 5C, the two lateral ends 40 are fartherapart. FIG. 5D depicts the hyoid brace in proximity to the hyoid bone.

In one embodiment shown by FIG. 6A, the flex point comprises a clevispin 51. In another embodiment, the flex point comprises a hinge joint47, as in FIG. 7A. In a further embodiment, the hinge joint is limitedto a particular range of movement. In one embodiment, shown in FIG. 7B,the pivot joint comprises a ball and socket joint 48. In anotherembodiment depicted in FIG. 7C, the pivot joint comprises one or morewires 49. In another embodiment, the wires resist axial loading. Inanother embodiment, the wires resist axial loading but are capable oflimited flexion. In another embodiment, the pivot joint comprises one ormore ribbons 50, as illustrated in FIG. 7D.

In another embodiment depicted in FIG. 8A, the hyoid brace comprises twobrace arms 52 and a bridge 53 that is fastenable to the two brace arms50. The brace arms 52 are attachable to the hyoid bone 15, as shown inFIG. 8B. When fastened to the brace arms 52, the bridge 53 is capable ofaltering the relative spatial orientation of the brace arms 52. In oneembodiment, push members 54, protrude from the inner surface 55 of thebridge 53 to apply force to the medial ends 41 of the brace arms 52. Inone embodiment, the bridge 53 has a wider shape than the curvature ofthe hyoid bone 15 and may spread apart the greater horns 23 of the hyoidbone upon attachment to the brace arms 52. In one embodiment in FIG. 8C,the bridge 53 has both push members 54 and a wider shape. The bridge 53optionally allows lateral displacement of the hyoid bone in addition towidening of the angle. In still another embodiment, the hyoid bonesegments are laterally displaced but the relative angle of the twopieces is generally unchanged. In one embodiment, shown in FIG. 9,lateral displacement is provided by a slotted tongue 54 inserted into ascrew mechanism 55. Similarly, anterior-posterior displacement may occurif the tongue 54 and screw mechanism 55 were positioned more laterallyalong the hyoid bone 15. The bridge 53 attaches to the brace arms 39 byclips 56. In another embodiment in FIG. 10, the operator will select abridge 53 from a variety of sizes to join the brace arms 52 and alterthe separation of the brace arms 52 and the attached hyoid bone. Inanother embodiment, the hyoid hone segments are laterally displaced butthe relative angle of the two pieces is generally unchanged. In oneembodiment the bridge 53 may attach to the brace arms 52 by a pluralityof clips 56. In one embodiment the bridge attaches to the brace armsthrough eyelets 57 or slots on the outer surface 43 of the brace arms52. In one embodiment, the bridge 53 and the brace arms 52 haveconnectors (not shown) to allow suturing of the hyoid brace tosurrounding structures and to further modify the hyoid bone position.

In another embodiment, the hyoid brace may have more than two segments58 which are attached by two or more pivot joints or bridges, as inFIGS. 11A to 11C.

1. Attachment of the Hyoid Brace to the Hyoid Bone or Bone Segments

In one embodiment, the hyoid brace is attached to the hyoid bone 15 orhyoid bone segments. In one embodiment illustrated in FIG. 12A bonescrews 59 are used to attach the hyoid brace. In another embodiment inFIG. 12B the attachment occurs with clips 60 on each side of the brace.In another embodiment in FIG. 12D the brace is attached using sutures orsurgical wire 61. In one embodiment in FIGS. 6A and 6B, hooks 62 areused to attach the hyoid brace to the hyoid bone 15. In anotherembodiment, adhesives are used to attach the hyoid brace. In anotherembodiment, illustrated in FIG. 12B, a combination of attachments areused.

In one embodiment shown in FIG. 12A, the hyoid brace is attachable tothe hyoid bone 15 or bone segments by bone screws 59. The hyoid bracemay have one or more screw holes 63 that run from the outer surface tothe inner surface 42 of the brace arm 39. In one embodiment, the screwholes 63 or other landmarks on the hyoid brace allow the operator toidentify the location of the holes 63 by palpation or by radiographicmethods. With the identification of the location of the screw holes, anoperator may create additional access for drilling into the hyoid bone15 or bone segments and securing the hyoid brace to the hyoid bone 15 orbone segment by inserting a bone screw 59 through the hyoid brace andscrew hole 63.

In one embodiment shown in FIGS. 12B and 12C, the hyoid brace comprisesclips 60, the clips 60 comprising a plurality of partially flexiblemembers 64 extending from superior 44 and inferior 45 surfaces of thebrace arms 39. The partially flexible members 64 have a distal end 65and a configuration with an inner surface 66 facing the hyoid bone 15.The configuration may be any path from one point on or about the hyoidbone 15 to another point on or about the hyoid bone sufficient to resistdisplacement of the hyoid brace arms 39 from the hyoid bone 15. Theconfiguration may be an angled bracket or a curved clip. The members 64are sufficiently flexible such that with an application of force againstthe member 64, the distal ends 65 of the members will flex apart fromeach other. In one embodiment, where the force results from pressing thebrace arm 39 against the hyoid bone 15, the flexion allows the hyoidbone 15 or bone segment to come in proximity of the inner surface of thehyoid brace arm 39. After contact, the flexible members 64 revert backto their previous configuration and secure the brace arms 39 to thehyoid bone 15 or bone segments.

In one embodiment, sutures 61 are removably attached to the hyoid brace.In one embodiment, depicted in FIG. 12D, the sutures 61 are used toattach the hyoid brace to the hyoid bone 15 or hyoid bone segments. Thesuture 61 may be cut after the brace arms are attached. Optionally,these sutures 61 may be attached to surrounding structures in the neckor mandible to provide additional support or anchoring of the hyoidbrace and hyoid bone. In another embodiment, the sutures 61 may bebrought out through the skin to provide additional control of thelateral ends 40 of the brace during the attachment procedure. In oneembodiment, the sutures 61 are attached to the lateral ends 40 of thebrace arms 39. In another embodiment, sutures 61 are attached to thelateral 40 and medial ends 41 of the brace arms 39.

In another embodiment shown in FIGS. 6A and 6B, the hyoid bracecomprises at least one hook 62 extending from at least one arm of thehyoid brace. The hook may pierce a portion of the surroundingmusculature or connective tissue to engage the hyoid brace with thehyoid bone 15 to at least partially hold the hyoid brace next to thehyoid bone 15. In one embodiment, the hyoid brace is positioned adjacentto the hyoid bone 15 and then rotated about its longitudinal axis untilthe hooks engage around the hyoid bone 15. A portion or all of the bracearm 52 may also comprise a helical configuration, so that it may bedistally advanced with rotation to encircle the corresponding greaterhorn 23 of the hyoid bone 15.

In another embodiment, an interference fit is provided between the hyoidbrace and hyoid bone by creating a passage through at least a portion ofthe hyoid bone and inserting the brace arm or extension therefrom intothe passage. In one embodiment, the passage is created through an innercore of the hyoid bone. In another embodiment, the passage extendsbetween an outer anterior or lateral surface of the hyoid bone and aninner surface of the hyoid bone. A hyoid brace inserted into the passagefrom the outer to inner surface of the hyoid bone allows manipulation ofthe hyoid brace to apply a, outward force to the inner surface of thehyoid bone. Alternatively, the hyoid brace may originate from about theouter anterior surface of the hyoid bone, extend bilaterally over thesuperior or inferior surfaces to contact the inner surfaces of the hyoidbone and apply a radially outward force.

In another embodiment of the present invention, the hyoid brace isadapted for implantation in the tissue adjacent to the hyoid bone orother tissue comprising the pharynx. The pharynx, as used herein, isgiven its ordinary meaning and also includes the pharyngeal mucosa,pharyngeal submucosa, pharyngeal musculature, hyoid bone, infrahyoidmuscles, suprahyoid muscles and any connective tissue between. The braceis inserted into the soft tissue adjacent to the hyoid bone orpharyngeal wall and manipulated to exert sufficient force to dilateportions of the pharyngeal wall or support the pharyngeal walls fromcollapse. The screws, clips, hooks or sutures of the previousembodiments of the invention or other soft tissue anchors may be adaptedto secure the brace to the soft tissue of the pharyngeal wall. Inanother embodiment, the implant resides within and relies on the naturalfascial planes of the neck musculature to affix its position and doesnot require any additional attachment to muscle. In one embodiment, thebrace arms are inserted into fascial planes between the stylohyoid- andhyoglossus muscles. In another embodiment, the brace arms are insertedinto the fascial planes between the hyoglossus and mylohyoid muscles. Inanother embodiment, the brace arms are inserted posterior to theposterior belly of the digastric muscle and anterior to the stylohyoidmuscle. In still another embodiment, the brace arms are placed betweenthe superior belly of the omohyoid and thyrohyoid muscles. The bracearms are then manipulated to achieve a lateral separation and thenlocked or caused by internal bias to retain their relative positions.

2. Configuration Lock of the Hyoid Brace

In one embodiment, shown in FIGS. 13A and 13B, a configuration lock 67is located between the two brace arms 39 and is attachable to both bracearms 39. The configuration lock 67 comprises a locking member 68 with atleast one interfaceable end 69 and at least one locking interface 70located on a brace arm 39. When the interfaceable end 67 of the lockingmember 68 is in contact with the locking interface 70 of the brace arms39, the locking member 68 limits the movement, if any, of a brace arm 39relative to the other brace arm 39 or brace arms 39.

In one embodiment, the locking member 68 comprises an elongated member71 with two interfaceable ends 67 at least one of which comprises athreaded end 72. Each brace arm 39 has an interface for receiving themember 71, at least one of which has a locking interface 70 comprising athreaded hole 73. The threaded hole 73 is matched to the threaded ends72 of the elongated member 71 such that the elongated member 71 may passaxially through the threaded hole 73 by applying a rotation force to theelongated member 71. In one embodiments the locking interface 70comprises a threaded hole 73 within a cavity 74 of the brace arm 39. Thecavity 74 may have one or more openings 75. When the threaded ends 72 ofthe elongated member 71 are screwed into the threaded locking interfaces70, the relative position and angle formed by the brace arms 39 may befixed. In one embodiment, the position and angle may be reversiblyadjusted by rotating the elongated member 71. In one embodiment, thelocking interface 70 comprises a threaded hole 73 in a protrusion 76from the brace arm 39, as shown in FIGS. 14A and 14B.

As is illustrated herein, a variety of different configurations of theimplant may be devised in which a rotatable threaded shaft 71, depictedin FIG. 15A, is utilized both to adjust the angular orientation of theimplant, as well as retain the implant in a predetermined orientation.This allows the clinician to rotate a driver tool 78, represented inFIG. 15C, coupled to the rotatable shaft 71 thereby adjusting theangular orientation of the implant throughout a continuous range. Oncethe desired manipulation of the hyoid bone 15 has been accomplished, thedeployment tool 78 may be decoupled from the rotatable shaft 71, and theimplant will retain its predetermined configuration.

The adjustment tool 78 (e.g., an elongate rotatable shaft having ananti-rotation coupling thereon for interlocking with a correspondingcomplementary interlocking surface on the rotatable shaft 71) may beoriented coaxially with the rotatable shaft 71. In this configuration, alinear coaxial access lumen is preferably provided such as bylengthening the lumen or threaded hole 73 along its longitudinal axisthrough the implant until it exits the implant, thereby enabling directaxial connection of the adjustment tool. This lateral approach isillustrated, for example, in FIG. 15E, however may be applied to any ofthe rotational embodiments herein.

Alternatively, it may be desirable to adjust the implant from ananterior approach. In this configuration, a 90° or other bend in theaxis of rotation may be provided, utilizing gear mechanisms wellunderstood in the art, allowing the rotation of an adjustment tool whichlies along an anterior-posterior axis to translate rotation into theelongated member 71, which lies in a lateral axis perpendicular or at anon normal angle to the anterior-posterior axis.

In one embodiment, represented in FIG. 15A, one or both of the threadedends 72 may optionally have a rotation interface 77, as in FIG. 15B, sothat the tool 78, seen in FIG. 15C with a complementary interface 79 canbe applied to the threaded end 72 to facilitate rotation of theelongated member 71. In one embodiment, the rotation interface 77 is aslot in the end of the elongated member 71 and the tool 78 is ascrewdriver with a complementary interface 79 comprising a flat endfitiable to the slot. In another embodiment, the rotation interface 77is a hex or other noncircular configuration recess or projection headand the tool 78 is a hex screwdriver or other complementary surfacestructure. In one embodiment, depicted in FIGS. 15D and 15E, the cavity74 containing the locking interface 70 has at least two openings 75. Oneopening 75 accepts the threaded end 72 of the elongated member 71.Another opening 75 provides access to the rotation interface 77 of theelongated member 71.

As will be appreciated in view of the disclosure herein, rotation of theelongated member 71 in a first rotational direction will advance theelongated member 71 distally along its longitudinal axis, therebyclosing the angle between the first and second arms of the implant.Rotation of the elongated member 71 in an opposite direction will enableopening of the angle between the first and second arms of the implant.In this manner, the angular orientation of the arms 39 of the implantmay be adjusted throughout an angular range.

In another embodiment, the elongated member 71 further comprises agrippable surface between the two threaded ends 72. In one embodiment,illustrated in FIG. 16A, the gippable surface comprises a dial 81. Inone embodiment, shown in FIG. 16B, the grippable surface comprises twoor more flat surfaces 82 along the elongated member 71.

In one embodiment, depicted in FIG. 17A, the pivot joint of the hyoidbrace is located closer to the inner (posterior) surface 42 of the hyoidbrace relative to a configuration lock 67. In another embodiment,represented in FIG. 17B, the pivot joint is located closer to the outer(anterior) surface 43 of the hyoid brace relative to the configurationlock 67. Thus, the threaded shaft 67 may be located such that it iseither under tension or under compression while restraining the hyoidbone 15 in its modified orientation.

In another embodiment, shown FIG. 18A, the locking member 68 comprisesan elongated member 71 that is semi-flexible and has a ramped surface 83that allows insertion through a locking interface 70 in one directionbut acts as a ratchet to resist movement in the opposite direction. Inanother embodiment, illustrated in FIG. 18B, the locking member 68comprises a beaded wire 84 with a locking interfaces 70 that allowpassage of wire 85 but not beads 86, as seen in FIG. 18C.

In one embodiment, one or more locking interfaces 68 may provide somerelative movement between itself and the brace arm 39 to which it isattached. This relative movement may be desirable to accommodate angularchanges in the position between the locking member 68 with the brace arm39 as the configuration lock 67 is adjusted to the desired position. Inone embodiment, illustrated in FIG. 19A, the locking interface 70provides some relative movement through limited flexibility of aprotrusion 76 of the brace arm 39. In another embodiment, relativemovement is provided by hinge joints (not shown) attaching the lockinginterfaces 68 to the brace arms 39. In another embodiment, depicted inFIG. 19B, some relative movement is provided by a threaded nut 87 in acavity 74 of the brace arm 39 that is slightly loose in the cavity 74 toallow some tilting of the threaded nut 87, but is not enough to allowrotation or longitudinal displacement of the nut 87 within the cavity74. In one embodiment, the cavity 74 provides entry of the lockingmember 68 at a range of angles.

In another embodiment, depicted in FIG. 20A, the brace arms 39 of thehyoid brace are pivotable and/or semi-flexible and the locking member 68comprises wires 90 with proximal 91 and distal ends 92 that areslideable along conduits 93 located in the brace arms 39 closer to theouter surface 43, and a cinching member 94 that controls the sliding ofwires 90. The locking interfaces 68 of the brace arms 39 comprise anattachment of the distal ends 92 of the wires 90 to the lateral ends 40of the brace arms 39. As the wires 90 are pulled from a lateral tomedial direction, the inner 42 and outer surfaces 43 of the brace arms39 will shift at different rates and cause the brace arms to flexoutward and widen the angle formed by the attached hyoid bone 15 orhyoid bone segments. In another embodiment, shown in FIG. 20B, theconduits 93 comprise a plurality of eyelets 95 protruding from the outersurface. 43 of the brace arms 39. In another embodiment shown⁻in FIGS.11A to 11C, more than two brace arms 39 are used with the wire-basedconfiguration lock. In one embodiment, the cinching member mayreversibly control the sliding of the wires 90 through reversiblefriction. In another embodiment, the cinching member 94 reduces slidingof the wires 90 through heating bonding to the wires 90.

In another embodiment, represented in FIGS. 21A and 21B, the lockinginterface comprises a plurality of holes 96 on the brace arms 39 withthe configuration lock comprising at least one suture 97 threadedbetween holes 96 on two different brace arms 39.

In one embodiment, as shown in FIG. 22A, a torsion spring 98 is locatedabout a hinge joint 47. The torsion spring-98 has two ends 99, depictedin isolation in FIG. 22B, that extend distally to apply force to thebrace arms 39 to widen the angle formed by the brace arms to the maximumallowed by the hinge joint. The ends 99 of the torsion spring 98 may beembedded within the brace arms 39 or the ends 99 may be located externalto the brace arms 39 against the inner surface 42 of the brace arms. Thespring tension may be selected to allow at least narrowing of the angleformed by the brace arms during swallowing or speaking.

3. Materials for Construction of the Avoid Brace

For the embodiments discussed herein, the hyoid brace, together with theconfiguration lock and other components of the present invention can bemanufactured in accordance with any of a variety of techniques-which arcwell known in the art, using any of a variety of medical-gradeconstruction materials. For example, the hyoid brace and othercomponents of the present invention can be injection-molded from avariety of medical-grade polymers including high or other densitypolyethylene, nylon and polypropylene. Portions of the configurationlock can be separately formed from the brace arms and secured thereto ina post-molding operation, using any of a variety of securing techniquessuch as solvent bonding, thermal bonding, adhesives, interference fits,pivotable pin and aperture relationships, and others known in the art.Preferably, however, the configuration lock is integrally molded withthe brace arms, if the desired material has appropriate physicalproperties.

A variety of polymers which may be useful for the hyoid brace componentsof the present invention are identified below. Many of these polymershave been reported to be biodegradable into water-soluble, non-toxicmaterials which can be eliminated by the body:

Polycaprolactone

Poly (L-lactide)

Poly (DL-lactide)

Polyglycolide

Poly (L-Lactide-co-D, L-Lactide)

70:30 Poly (L-Lactide-co-D, L-Lactide)

95:5 Poly (DL-lactide-co-glycolide)

90:10 Poly (DL-lactide-co-glycolide)

85:15 Poly (DL-lactide-co-glycolide)

75:25 Poly (DL-lactide-co-glycolide)

50:50 Poly (DL-lactide-co-glycolide)

90:10 Poly (DL-lactide-co-caprolactone)

75:25 Poly (DL-lactide-co-caprolactone)

50:50 Poly (DL-lactide-co-caprolactone)

Polydioxanone

Polyesteramides

Copolyoxalates

Polycarbonates

Poly (glutamic-co-leucine)

The desirability of any one or a blend of these or other polymers can bedetermined through routine experimentation by one of skill in the art,taking into account the mechanical requirements, preferred manufacturingtechniques, and desired reabsorption time. Optimization can beaccomplished through routine experimentation in view of the disclosureherein.

Alternatively, the hyoid brace components can be molded, formed ormachined from biocompatible metals such as Nitinol, stainless steel,titanium, and others known in the art. In one embodiment, the componentsof the hyoid brace are injection-molded from a bioabsorbable material,to eliminate the need for a later removal step or to promote fibrosisand fixation of adjacent structures. One suitable bioabsorbable materialwhich appears to exhibit sufficient structural integrity for the purposeof the present invention is poly-p-dioxanone, such as that availablefrom the Ethicon Division of Johnson & Johnson. Poly (L-lactide, orco-DL-lactide) or blends of the two may alternatively be used As usedherein, terms such as bioabsorbable, bioresorbable and biodegradableinterchangeably refer to materials which will dissipate in situ,following a sufficient post-operative period of time, leaving acceptablebyproducts. Bodily reaction to the bioabsorbable materials or byproductsmay furnish at least a portion of the support provided by the device ortreatment method. All or portions of any of the devices herein, as maybe appropriate for the particular design, may be made from allograftmaterial, or synthetic bone material.

The bioabsorbable implants of this invention can be manufactured inaccordance with any of a variety of techniques known in the art,depending upon the particular polymers used, as well as acceptablemanufacturing cost and dimensional tolerances as will be appreciated bythose of skill in the art in view of the disclosure herein. For example,any of a variety of bioabsorbable polymers, copolymers or polymermixtures can be molded in a single compression molding cycle, or thesurface structures can be machined on the surface of the hyoid braceafter the molding cycle. It is also possible to use the techniques ofU.S. Pat. No. 4,743,257, the entire disclosure of which is incorporatedherein by reference, to mold absorbable fibers and binding polymerstogether.

An oriented or self-reinforced hyoid brace can also be created duringextrusion or injection molding of absorbable polymeric melts through asuitable die or into a suitable mold at high speed and pressure. Whencooling occurs, the flow orientation of the melt remains in the solidmaterial as an oriented or self-reinforcing structure. The mold can havethe form of the finished brace component, but it is also possible tomanufacture the brace components of the invention by machininginjection-molded or extruded semifinished products. It may beadvantageous to make the hyoid brace from melt-molded, solid state drawnor compressed, bioabsorbable polymeric materials, which are described,e.g., in U.S. Pat. Nos. 4,968,317 and 4,898,186, the entire disclosuresof which are incorporated herein by way of this reference.

Reinforcing fibers suitable for use in the components of the presentinvention include ceramic fibers, like bioabsorbable hydroxyapatite orbioactive glass fibers. Such bioabsorbable, ceramic fiber reinforcedmaterials are described, e.g., in published European Patent ApplicationNo. 0146398 and in WO/96/21628, the entire disclosures of which areincorporated herein by way of this reference.

As a general feature of the orientation, fiber-reinforcement orself-reinforcement of the brace components, many of the reinforcingelements are oriented in such a way that they can carry effectively thedifferent external loads (such as tensile, bending and shear loads) thatare directed to the hyoid brace as used.

The oriented and/or reinforced hyoid brace materials for manyapplications have tensile strengths in the range of about 100-2000 MPa,bending strengths in the range of about 100-600 MPa and shear strengthsin the range of about 80-400 MPa, optimized for any particular designand application. Additionally, they are relatively stiff and tough.These mechanical properties may be superior to those of non-reinforcedor non-oriented absorbable polymers, which often show strengths betweenabout 40 and 100 MPa and are additionally may be flexible or brittle.See, e.g., S. Vainionpaa, P. Rokkanen and P. Tormnld, “SurgicalApplications of Biodegradable Polymers in Human Tissues”, Progr. Polym.Sci., Vol. 14, (1989) at 679-716, the full disclosure of which isincorporated herein by way of this reference. in other embodiments ofthe present invention, a semi-flexible material is desired to provide aresilience so that normal swallowing and speaking are not impaired.

The brace components of the invention (or a bioabsorbable polymericcoating layer on part or all of the brace surface), may contain one ormore bioactive substances, such as antibiotics, chemotherapeuticsubstances, angiogenic growth factors, substances for accelerating thehealing of the wound, growth hormones, antithrombogenic agents, bonegrowth accelerators or agents, and the like. Such bioactive implants maybe desirable because they contribute to the healing of the injury inaddition to providing mechanical support.

C. Placement of a Hyoid Brace

1. Surgical Approach

In one embodiment as depicted in FIG. 23A, the head of the patient isplaced in an extended position to facilitate access to the upper neck.The skin of the neck is sterilized and draped using procedures wellknown to those with skill in the art. Applying sterile technique andusing the thyroid cartilage 16 as a landmark, the hyoid bone 15 ispalpated, if possible, and an incision site is identified about themidline of the hyoid bone. In one embodiment, the skin is injected withanesthetic containing epinephrine until anesthesia is achieved. About a2 to about a 5 cm incision is made in the skin generally overlying themidportion of the hyoid bone 15. In one embodiment, the incision is avertical incision, shown in FIG. 23B. In another embodiment, theincision is a horizontal incision. The subcutaneous tissue is dissecteduntil the platysma muscle is reached. Skin retractors are used tomaximize and maintain the visibility of the exposed incision site. Atleast a 1 cm vertical midline incision is made in the platysma muscle toexpose at least a portion of the hyoid bone. Blunt dissection is thenperformed along the hyoid bone 15 to each lateral side of the incisionsite to create a dissected space and to facilitate insertion of a hyoidbrace along the anterior surface of the hyoid bone 15. Muscles attachedto the hyoid bone may be transected to facilitate visibility of thesurgical site, attachment of the hyoid brace, expansion of thepharyngeal airway, or to alter the movement of the hyoid bone, but isnot limited to any these particular purposes. The hyoid brace is thenattached to the hyoid bone as previously described and illustrated inFIGS. 23C through 23G. In one embodiment, additional access sites arecreated to the dissected space. Additional access sites may be createdby passing an instrument from the dissected space out through the skinof the neck. In another embodiment, access sites are created bypuncturing the skin of the neck and inserting an instrument to thedissected space. Other variant approaches will be apparent to thoseskilled in the art, such as otolaryngologists, including endopharyngealapproaches. In another embodiment, a midline incision is made in theskin about 2 to about 4 cm above the hyoid bone and the subcutaneoustissue is dissected until the suprahyoid Muscles are reached. The braceis attached to the suprahyoid musculature or inserted into fascialplanes between the suprahyoid muscles. The suprahyoid muscles may bedissected further to implant the brace closer to the inner wall of thepharynx. In another embodiment, the midline incision is made about 1 toabout 4 cm below the hyoid bone and the brace is inserted into orattached to the infrahyoid musculature.

In one embodiment, the hyoid bone 15 is not cut but is bent to a widerangle. In another embodiment, the hyoid bone 15 is cut prior to theinsertion of the hyoid brace. In another embodiment the hyoid bone 15 iscut after the insertion of the hyoid brace into the dissection space butprior to the attachment of the hyoid brace to the hyoid bone 15. Instill another embodiment, the hyoid bone 15 is cut after the brace isattached to the hyoid bone 15. In another embodiment, the brace isadjustable after attachment to the hyoid bone 15 such that position andangle of the hyoid bone segments may be reversible changed at any time.In one embodiment, the segments of the hyoid bone 15 may immediatelyassume the desired position and angle after cutting from of the forcesapplied to the hyoid bone segments by the attached brace. In oneembodiment the hyoid bone 15 is cut at about the midline. In anotherembodiment the hyoid bone is cut anywhere between the lesser horns. Inanother embodiment the hyoid bone is cut anywhere between the greaterhorns. In another embodiment, the hyoid bone is cut into multiplesegments. In another embodiment the hyoid bone is cut twice, with eachcut made just at or about medial to each lesser horn. In one embodiment,illustrated in FIGS. 24A and 24B, a spacer 120 is inserted between orabout the hyoid bone segments. In one embodiment, represented in FIGS.24C and D, the spacers 121 are adjustable in size after insertion. Inanother embodiment, graft materials (not shown) are inserted between orabout the hyoid bone segments. The graft material may be an autograft,allograft, xenograft or synthetic material. Synthetic graft material maybe ceramic-based, silicon-based or calcium-based. The graft material mayalso include osteoinductive factors to promote bone ingrowth. In anotherembodiment, spacers and synthetic graft material are inserted between orabout the hyoid bone segments. One skilled in the art will appreciatethat there are many varieties of synthetic graft materials andconstituents that may be used to between or about the hyoid bonesegments.

In one embodiment, the brace is adjustable after attachment to the hyoidbone 15 such that position and angle of the hyoid bone segments may bereversibly changed at any time. In one embodiment, after the hyoid braceis attached to the hyoid bone 15 or bone segments, the attachment of thebrace is checked and adjusted if necessary and the incision and puncturesites are closed as known by those skilled in the art. In one embodimentthe incision sites are closed by sutures. In another embodiment theincision sites are closed by adhesives. In another embodiment, the woundis covered with dressings. In one embodiment, airway patency is assessedduring the procedure and for a period of time after the procedure toensure stability of the brace and hyoid bone. In one embodiment, suturesarc optionally used to permanently or temporarily stabilize the hyoidbone or bone segments for attachment of the hyoid brace. The sutures areplaced around the hyoid bone 15 so that the free ends of the suturesextend outside the body and the operator may apply a pulling force tothe sutures to resist any inward force applied to the hyoid bone 15 orbone segment during the attachment process. Alternatively, the suturesmay be attached to other structures of the body.

In one embodiment, the apparatus and method for hyoidplasty is adaptedto repair a fractured hyoid bone 15 resulting from neck trauma.

2. Minimally Invasive Approach

a. Delivery Member for the Hyoid Brace

One embodiment of the invention, shown in FIG. 25A, comprises a deliverymember 100 having a core 101 with a proximal end 102 and a distal end103, an outer sheath 104 with a proximal end 105 and a distal end 106and a fastener with a proximal end 108 and distal end 109. In oneembodiment, the delivery member 100 is a flexible catheter. In anotherembodiment, the delivery member is a rigid instrument. In oneembodiment, the delivery member 100 further comprises a handle 110 atthe proximal end 102 of the core 101. The delivery member 100 hassufficient rigidity to direct the placement of the hyoid brace or bracecomponents through various thicknesses of subcutaneous tissue. The hyoidbrace or brace components are attachable to the distal end 103 of thecore 101 by a fastener 107. In one embodiment, the fastener 107comprises a clamp 111 or forceps attached to the distal end 103 of thecore 101 that may be optionally controlled by the proximal end 108 ofthe fastener 107 located at the proximal end 102 of the core 101 througha push button 112 or a squeeze lever that releases the clamp 111 orforceps, as is known to those skilled in the art. In another embodiment,depicted in FIG. 25B, the fastener 107 is a wire 113 or suture thatextends through the core 101 from proximal to distal, loops around thehyoid brace near the medial ends of the hyoid brace and extends backthrough the core 101 from distal to proximal. Both ends of the wire 113or suture are located at the proximal end 102 of the core 101 and areattached to a proximal anchor 115. In one embodiment, the wire 113 orsuture is sufficiently taut to hold a portion of the hyoid brace againstthe distal end 103 of the core 101. A outer sheath 104 is positionedaround the distal end of the core, having an extended position and aretracted position. In the extended position, the outer sheath 104generally overlies the hyoid brace. In one embodiment, the outer sheath104 in the extended position prevents the hyoid brace from changing froman unfolded position to a folded position. In the retracted position,the hyoid brace is generally exposed and the outer sheath 104 does notprevent the hyoid brace from unfolding. In one embodiment, an outerprojection 116 on the core 101 and an inner projection 117 on the outersheath 104 block the outer sheath 104 from extending past an extendedposition. The hyoid brace is releasable from the distal end 103 of thecore 101 by freeing one end of the wire 113 or suture and pulling thewire 113 proximally to remove the loop of wire or suture about themedial ends 41 of the hyoid brace.

In another embodiment, illustrated in FIGS. 26A and 26B, the deliverymember comprises a catheter or insertion tool having a core 101 with aproximal end (not shown) and distal end 103, and an outer sheath 104.The distal end 103 of the core 101 has a surface 118 configured foraffixing brace arms 52. The outer sheath 104 is slideable along thelength of the core 101 and is capable of encompassing both the core 101and the brace arms 52. The delivery member is inserted into thedissected area and positioned to release the brace arm 52 at a desiredposition. The outer sheath 104 is withdrawn to expose the core andrelease the hyoid brace arm. The core surface 118 is configured toprevent mobility of the brace or parts thereof as the outer sheath iswithdrawn, but is configured to allow withdrawal of the core 101 whileleaving the brace arm at the dissected site. In one embodiment, the core101 and outer sheath 104 allow attachment of the brace arms 52 to thehyoid bone or bone segments prior to release of the brace arm 52 in thedissected space. The outer sheath 104 has at least one linear opening119 along the distal end 106 of the outer sheath 104 to allow sliding ofthe sheath 104 after the brace arm 52 has been at least partiallyattached to the hyoid bone 15 or bone segments. In one embodiment, atleast one of the linear openings 119 has a shape conformable to a hyoidbone 15 to facilitate alignment of the brace arm 52 with the hyoid bone15 or bone segments. In one embodiment, the outer sheath 104 is capableof rotation around the core 101. In one embodiment, rotation of theouter sheath 104 exposes the hooks 62 or clips 60 of the brace arm 52.In one embodiment, placing the outer sheath 104 in a retracted positionexposes the hooks 62 or clips 60.

In one embodiment, the delivery member 100 has a diameter ranging fromabout 16 French to about 22 French. In another embodiment, the diameterranges from about 10 French to about 22 French. In another embodiment,the diameter ranges from about 4 French to about 24 French. In oneembodiment, the delivery member has a length of about 6 cm to about 10cm. In another embodiment, the length is about 6 cm to about 20 cm.

In one embodiment, the outer sheath 104 has palpable markings (notshown) on the core 101 or outer sheath 104 for a clinician to determinethe location of the delivery member 100 by tactile sensing. In oneembodiment the palpable markings are used by the operator for theplacement of puncture access sites lateral to the midline incision site.In one embodiment the delivery member 100 has radiographically visibleembedded markers that are visible under fluoroscopy or plain filmx-rays. In one embodiment, the outer sheath 104 has a groove (not shown)to facilitate alignment of the delivery member 100 to the hyoid bone 15or bone segments.

In another embodiment, the delivery member 100 comprises one or moresutures brought through the initial incision site and extended throughthe dissected area along the hyoid bone 15 and exit the body through apuncture site lateral to the initial incision site. The sutures may beused to guide the brace components to the intended attachment site andalso to attach the brace components to the hyoid bone.

In one embodiment, the delivery member further comprises one or moreguidewires inserted the initial incision site. In one embodiment, theguidewire extends through the dissected area along the hyoid bone andexit the body through a puncture site lateral to the initial incisionsite. In one embodiment, the core 101 further comprises a guidewirelumen (not shown) running generally from the proximal end to the distalend 103 of the core 101.

In one embodiment, the delivery member 100 has a blunt tip and may alsoserve as a blunt dissection instrument. Blunt dissection with thedelivery member 100 may be performed prior to attachment of the hyoidbrace or brace components to the delivery device 100, or concurrently asthe brace arm 52 is attached to the hyoid hone.

In one embodiment the manufacturer provides a hyoid brace that ispreattached to the delivery device 100. In another embodiment theoperator attaches the hyoid brace to the delivery device 100 prior touse. In another embodiment the operator selects from a variety of braceswith different curvatures and configuration angles and attaches thebrace to the delivery device 100.

b. Procedure for Minimally Invasive Insertion

The head of the patient is placed in an extended position to facilitateaccess to the upper neck, as depicted in FIG. 23A. The skin of the upperneck is sterilized and draped using procedures well known to those withskill in the art. Applying sterile technique and using the thyroidcartilage as a landmark, the hyoid bone is palpated, if possible, and anincision site is identified about the midline of the hyoid bone 15. Inone embodiment, the skin is injected with anesthetic containingepinephrine until anesthesia is achieved. In one embodiment, about a 2cm incision is made in the skin generally overlying the midportion ofthe hyoid bone. In one embodiment, the incision is a vertical incision.In another embodiment, the incision is a horizontal incision. Thesubcutaneous tissue is dissected until the platysma muscle is reached.Skin retractors are used to increase and maintain the visibility of theexposed incision site. At least a 1 cm vertical midline incision is madein the platysma muscle to expose at least a portion of the hyoid bone.Blunt dissection is then performed along the hyoid bone to each lateralside of the incision site to create a dissected space and to facilitateinsertion of a hyoid brace along the anterior surface of the hyoid bone.In one embodiment, blunt dissection is initiated by curved surgicalforceps. In another embodiment, blunt dissection is performed by acurved blunt dissection instrument having a curvature portion thatgenerally approximates the curvature of the hyoid bone from the midlineto at least the lesser horn, or more. In one embodiment, hemostasis ofthe incision and dissection area is achieved using an electrocauterydevice known to those skilled in the art.

In one embodiment the blunt dissection instrument is used to measure thesize and configuration of the hyoid bone 15. In another embodiment, theblunt dissection instrument further comprises a distal end with animaging sensor. In one embodiment the size and configuration informationmay be used to select a particular brace appropriate to particularcharacteristics of the hyoid bone to be treated. In another embodimentthe blunt dissection instrument is palpable through the skin to allowthe operator to determine the extent of dissection and to allow theoperator place puncture sites lateral to the initial incision site tofacilitate manipulation of instruments and an attachment of a brace ontothe hyoid bone.

In one embodiment, the hyoid brace is inserted into the dissection spaceand approximately against the surface of the hyoid bone 15. In oneembodiment, the placement of the hyoid brace or brace components isperformed under ultrasound guidance. In one embodiment, the placement ofthe hyoid brace or brace components is performed under fluoroscopy. Inone embodiment, a hyoid brace in the folded position is inserted throughan incision site. After or during the insertion, the hyoid brace thenassumes the unfolded position in approximation along the hyoid bone 15.

In one embodiment, the hyoid brace is inserted manually by hand into thedissected area. In another embodiment, the hyoid brace is inserted intothe dissected area using a delivery member 100.

In another embodiment, brace arms 52 are inserted separately into thedissected space and attached to the hyoid bone 15. In some embodiments,a bridge 53 is used to connect each brace arm 52. In other embodiments,the brace arms 52 are configured to directly attach to each other whileseparating portions of the hyoid bone 15. In some embodiments, thebridge 53 allows adjustment of the relative position between the bracearms 52. The delivery member then releases the hyoid brace.

In another embodiment, the brace arms are inserted into the infrahyoidor suprahyoid musculature adjacent to the hyoid bone. Attachment of thebridge reconfigures the soft tissue about the hyoid bone and dilates orsupports the pharyngeal walls, depending upon the internal bias andflexibility of the brace arms and bridge.

D. Improved Hyoid Brace

In another embodiment of the invention, the implant comprises at leastone conformable or deformable bone engagement structure to provideincreased contact of the implant to the hyoid bone 15. FIGS. 27A through27D depict one embodiment of the implant 120 comprising two brace arms122, 124, each with a conformable bone engagement structure 126 attachedby connecting members 128 to the brace arms 122, 124. FIG. 27Aillustrates the brace arms 122, 124 in a joined configuration whileFIGS. 27B depicts the brace arms 122, 124 separately. In someembodiments of the invention, a conformable or deformable boneengagement structure 126 may be advantageous in engaging portions of thehyoid bone 15 because of the small size, irregular surfaces, and/orfragile characteristic of hyoid bone 15. A conformable or deformablebone engagement structure 126 may provide increased engagement of theimplant 120 to bone by distributing the engagement or clamping force ofthe implant 120 across a larger contact area. A non-conformable ornon-deformable bone engagement structure may exhibit focal localizationof the clamping or engagement force at focal points or smaller contactareas against the hyoid bone 15, thereby increasing the risk of fractureduring the attachment process or over time. A conformable or deformablebone engagement structure 126 may also enhance attachment of the implant120 to the hyoid bone 15 because the asymmetrical shape and/or theirregular surfaces of the hyoid bone 15 may reduce the contact surfacearea between the hyoid bone 15 and the implant 120. For example, in somepatients, the inner surface of the hyoid bone 15 is concave and/or theradial thickness of the hyoid bone tapers inferiorly. However, theinvention described herein need not be limited to these hypotheses.

Referring to back to FIGS. 27A through 27D, in one embodiment, theconformable bone engagement structure 126 comprises an elliptical shapedsurface 130 attached to a screw interface 132 by one or more struts 134.A complementary bone engagement surface 136 has. a lumen 138 capable ofaccepting a screw that can pass into the screw interface 132 of theconformable bone engagement surface 126. Typically, but not always, thehyoid bone 15 is drilled to allow the screw to pass through the hyoidbone 15 and reach the screw interface 132. In some embodiments, theimplant 120 may be configured such that the pathway from the lumen 138to the screw interface 132 is positioned eccentrically to the hyoid bone15 and a hole through the hyoid bone 15 is not required. The portions ofthe complementary bone engagement structure 136 may or may not beconformable also. Although FIGS. 27A through 27D depict a boneengagement structure 126 comprising an elliptical structure 130, oneskilled in the art will understand that any of a variety of boneengagement surfaces capable of deforming to increase the contact to abone may be used. Other shapes that may be used include but are notlimited to circles, rectangles, trapezoids, triangles, polygons or anyother closed or open shape. The bone engagement structure may alsocomprise any of a variety of three-dimensional structures, such as aspiral, lattice, conical or pyramidal structures. As depicted in FIGS.27A through 27D, the conformable hone engagement surface 126 may have anopen configuration where struts 134 attach the conformable boneengagement surface 126 to the screw interface 132. In other embodiments,the conformable bone engagement surface may have a closed configurationthat is directly attached to the screw interface 132 so that struts 130are not required.

FIGS. 28A and 28B are cross sectional views of one embodiment of theinvention demonstrating the deformation of the conformable boneengagement structure 126 to the hyoid bone 15. FIG. 28A depicts thebrace arm 124 of the implant 120 positioned about a portion of the hyoidbone 15. After creating a hole in the hyoid bone 15 between the lumen138 of the complementary engagement surface 136 and the screw interface132, a screw 140 may be inserted through the lumen 138 and hyoid bone 15to engage the screw interface 132. As the screw 140 further engages thescrew interface 132, the conformable engagement surface 126 is drawn toand contacts the surface of the hyoid bone 15 and deforms, increasingthe contact of the elliptical structure 130 to the hyoid bone 15.Multiple conformable bone engagement structures 126 and screw interfaces132 may be provided on each brace arm 122, 124. Furthermore, each bracearm 122, 124 and/or each complementary engagement surfaces 136 may alsohave optional eyelets or holes for attaching additional bone screws orother fasteners to the bone. These additional fasteners can partiallypenetrate and engage the hyoid bone 15 without requiring additional boneengagement structures 126.

As mentioned previously, for embodiments of the invention comprisingseparate joinable brace arms, any of a variety of friction fits,mechanical interfits and/or locking configurations may be used to engageand/or affix the brace arms to one another. These may include snapfitsthat do not require a fastener such as a screw, pin or bolt, or otherconfigurations that utilize one or more fasteners. The configurations ofthe brace arms may symmetrical or asymmetrical.

FIG. 27B depict one embodiment of the invention where one brace arm 122comprises a female interfit member 142 and the other brace arm 124comprises a male interfit member 144. The interfit between the femaleinterfit member 136 and the male interfit member 144 may be configuredto restrict the relative motion between the brace arms 122, 124 tovarious directions and/or degrees of motion. In some embodiments, asillustrated in FIGS. 29A and 2913, the male interfit member may comprisean elongate body 146 that is complementary to a female interfit memberconfigured as an elongated lumen 148, thereby restricting relativemovement between the brace arms along a single direction. In otherembodiments, as shown in FIGS. 30A and 30B, the female interfit member150 may have an upside-down U-shape to allow motion of the male member152 inferiorly, but restrict relative superior motion. FIG. 30C depictsa male member 153 with an additional reinforcement bar 155.

In some embodiments, as shown in FIGS. 27A through 27D, the brace armsmay be configured to have a single fixed alignment upon implantation. Inother embodiments, as shown in FIGS. 30A through 30C, multiple screwholes 157 may be provided on the brace arms that allow severalconfigurations between the same brace arms. The screw holes 157 may bepositioned on the brace arms to allow configurations of different widthsas well as different angulations between the brace arms.

Referring back to FIG. 27B, in a preferred embodiment, the femaleinterfit member 142 comprises dual-flat prongs 154, 156 while the maleinterfit member 144 comprises a single flat prong 158 configured to forman interfit between the dual-flat prongs 154, 156. This configuration ofthe implant 120 may be advantageous because it allows engagement of thetwo brace arms 122, 124 without requiring a substantial degree ofseparation between the arms 122, 124, for initial engagement as isrequired with the embodiment depicted in FIGS. 29A and 29B. Tofacilitate alignment of the complementary prongs 154, 156, 158 of arms122, 124, a pivot pin 159 or structure may be provided in the one of theinterfit members and a complementary pivot surface 160 may be providedwith the other interfit member. The pivot pin 159 or structure may be anintegrally formed structure of the brace arm, or may be a screw, bolt orother fastener that is inserted through one or both brace arms 122, 124.The interfit between the female and male interfit members 142, 144 maybe affixed by inserting one or more screws through grooved lumens 160 inthe female and/or male interfit members 136, 138.

The brace arms 122, 124 may optionally further comprise one or moreadditional structures to facilitate releasable attachment to a deliverytool. FIG. 31 is a frontal view of the implant 120 in FIG. 27A, showingone embodiment of releasable gripping structures 162 that may be used bya delivery tool to retain and manipulate the brace arms 122, 124 duringthe implantation process. Additionally, the delivery tool may alsoengage other portions of the brace arms 122, 124 to stabilize theimplant 120 during the implantation procedure. For example, the deliverytool may also reversibly engage the screw interfaces 132 posteriorly torestrain bone engagement structures 126 until the screw 140 has engagedthe screw interfaces 132.

E. Improved Delivery Tool

Although the manipulation of the hyoid bone may be performed usingtraditional surgical tools, due to the relatively small size of thehyoid bone and the limited surgical exposure that is preferably used toaccess the hyoid bone, implantation tools optimized to manipulate and toattach the hyoid brace may be useful in performing the procedureefficiently. This may be particularly true when attempting to drill ahole into the hyoid bone and to maintain the desired drill orientationfor attaching the brace device.

Referring to FIGS. 32A and 32B, in one embodiment of the invention, ahyoid brace delivery tool 200 is provided, comprising two clamp members202, 204 in a movable relationship with each other and having an openposition and a closed position. A locking assembly 206 is optionallyprovided between the two clamp members 202, 204 to releasably maintainthe delivery tool 200 in one or more positions without significant orcontinuous effort by the user. Each clamp member 202, 204 has a clampingsurface 208, 210, a distal end 212, 214 and a proximal end 216, 218.Typically, the implantation procedure occurs when the patient is in asupine position and with the neck extended, and the surgeon willapproach the hyoid bone from an antero-inferior position. In thisparticular embodiment, clamp surface 208 and clamp surface 210 may beadapted to clamp a hyoid bone segment at its anterior and posteriorsurfaces, respectively, relative to the surgeon implanting the device.The terms “anterior” and “posterior” as used herein refer generally totypical anatomical orientations with respect to the longitudinal accessof a patient in anatomical position, although the actual orientation mayvary due to anatomical variations, actual body position and in someinstances may be used interchangeably with “proximal” and “distal” whendescribing the anatomical approach from the surgeon's perspective. Thetwo clamp members 202, 204 are oriented so that the clamping surfaces208, 210 of each clamp member 202, 204 are generally opposed but notnecessarily contacting the other clamping surface 208, 210 at least whenthe delivery tool 200 is in the closed position. In the closed position,the clamp members 202, 204 are configured to engage the hyoid bonebetween the clamping surfaces 208, 210.

The clamp members 202, 204 may further comprise one or more bends alongthe length of the clamp member 202, 204 to improve the direction ofaccess to the hyoid bone. When a patient is in the typical supineposition, use of a straight delivery tool would require place thesurgeon's hand against the chest wall of a patient. By configuring theclamp members 202, 204 with anterior bends about their distal ends 212,214 and posterior bends about their proximal ends 216, 218 as depictedin FIG. 32B, allows the surgeon to access the hyoid from a hand positionaway from the chest wall.

At least one, and preferably both clamp members 202, 204 have a braceretaining structure 220, 222 that is adapted for releasable attachmentof at least a portion of the hyoid brace or brace component. A braceretaining structure 220, 222 allows the brace component to be releasablyattached to the delivery tool 200 in the open and/or closed positionsand to position or clamp the hyoid brace component against the hyoidbone. Once the clamp members 202, 204 are engaged to the hyoid bone, thehyoid bone segment and brace component maintain a fixed relationshipwith respect to the delivery tool 200 and may be securely manipulated tofacilitate attachment of the brace component. The brace retainingstructures 220, 222 are typically located about the clamping surface208, 210 of a clamping member 202, 204, but in other embodiments thebrace retaining structures 220, 222 may be located on another portion ofone or more clamp members 202, 204 that are generally adjacent to thespace between the clamping surfaces 208, 210. FIGS. 32C and 32D arelateral and isometric views of the distal end 212, 214 of the clampmembers 202, 204, and are described in greater detail below.

One or both clamp members 202, 204 may be provided with a fasteneropening or site which allows the use a fastener, such as a screw, toattach the hyoid brace to the hyoid bone while the delivery tool 200 isclamped to the hyoid bone. Optionally, a drill guide 224 may be providedto drill one or more fastener pathways into the hyoid bone that may beneeded to attach the brace components. In some embodiments, the drillguide 224 is a separate tool used to align the drill with respect to thehyoid bone. In other embodiments, the drill guide 224 is configured tocooperate with the hyoid brace delivery tool 200 to provide accuratedrilling through the hyoid brace component and/or delivery tool 200 asit is clamped to the hyoid bone. In the preferred embodiment, the drillguide assembly 224 is integral with one or both clamp members 202, 204.In the most preferred embodiments, the drill guide assembly 224 ismovably attached to one or more clamp members 202, 204 such that thedrill guide assembly 224 may be positioned into an alignment withrespect to the fastening sites of the hyoid brace. After drilling, thedrill guide assembly 224 may be moved away to provide greater access tothe fastener opening to affix the brace component to the hyoid bone.Specific embodiments of the delivery tool and its subcomponents areprovided below.

In one embodiment of the invention, as shown in FIGS. 32A and 32B, thedelivery tool comprises two clamp members 202, 204 that are pivotablyconnected at a pivot axis 226 between the proximal 216, 218 and thedistal ends 212, 214 of the clamp members 202, 204, similar to a pair ofscissors or a hemostat. The clamp members 202, 204 may be manipulated attheir proximal ends 216, 218 to move the distal ends 212, 214 of theclamp members 202, 204 between an open and a closed position. Theproximal ends 216, 218 of the clamp members 202, 204 are optionallyconfigured for fitted contact or gripping with the fingers and or palmarsurfaces of a user's hand to facilitate use of the delivery tool 200,including but not limited to the loop handles 228, finger triggers orany of a variety of ergonomic structures known in the art. In someembodiments, the clamp members 202, 204 may be biased to the openposition or closed position by a spring other bias member.

An optional position lock or locking assembly 206 may also be providedto maintain one or more relative positions between the two clamp members202, 204. In one embodiment, the locking assembly 206 comprises atoothed elongate member 230 attached to a clamp member 204 and a ratchetinterface 232 on the other clamp member 202, the ratchet interface 232having a interfacing structure, such as a pin 234, that is adapted toresist relative movement of the toothed elongate member 230 when the pin234 positioned between the teeth 236 of the toothed elongate member 23.In one embodiment, the toothed elongate member 230 is movably attachedto a clamp member 204 and the force between the toothed elongate memberand ratchet interface originates from a bias member 238 about the clampmember 204 and the toothed elongate member 230. The bias member 238 maycomprise a coil spring or leaf spring, and be attached to either a clampmember or toothed elongate member, or both. In other embodiments theratchet interface may be configured with a movable bias to interfacewith a toothed elongate member fixedly attached to the clamp memberthrough a range of angles and/or positions.

In the embodiment depicted FIGS. 32A and 32B, movement of the clampmembers is facilitated in one direction by the angulation of the teeth236 of the toothed elongate member 230, while resistance in the otherdirection exerted by the bias member may be overcome by displacing thedistal end 240 of the toothed elongate member 230 from the ratchetinterface 232. This may be performed by the user of the delivery toolwith the either hand. FIG. 33 depicts a preferred embodiment of theinvention where the toothed elongate member 230 further comprises atrigger handle 242 to facilitate the separation of the toothed elongatemember 230 ergonomically with the same hand that is manipulating thedelivery tool 200. In this particular embodiment, the bias member 238 ispreferably attached to the trigger handle 242 and located between theclamp member 204 and the trigger handle 242. This location of the biasmember 238 may the clamp members 202, 204 to achieve a smaller distancebetween the clamping surfaces 208, 210 compared to the embodiment inFIGS. 32A and 32B, thereby allowing use of the delivery tool 200 withsmaller structures.

In another embodiment depicted in FIG. 34A, the locking assembly 206comprises two toothed longitudinal members 230, each projecting from oneclamp member 202, 204 and biased toward the other toothed longitudinalmember 230. A cross-sectional view of this locking assembly 206 isprovided in FIG. 34B. This configuration allows the teeth 236 of eachtoothed longitudinal member 230 to intercalate with the teeth 236 of theother toothed longitudinal member 230 to resist relative movementbetween the clamp members 202, 204 in at least one direction. By anglingthe teeth 236, clamping by the clamping surfaces 208, 210 may befacilitated while providing resistance to the separation of the clampingsurfaces 208, 210. To separate the clamping surfaces 208, 210 once theimplantation procedure is completed, force is applied to the toothedlongitudinal members 230 to overcome their bias towards the each other,thereby separating the teeth and allow movement of the clamp members.One skilled in the art will understand that other complementarymechanical interfit members besides toothed longitudinal members 230 mayalso be used for the locking assembly 206, including locking thumbscrews adapted to form a mechanical or frictional fit between the clampmembers.

In the embodiments of the invention described above, the clamp members202, 204 are configured in a movable relationship wherein the clampingsurfaces 208, 210 are in a pivotable relationship, but other movablerelationships arc also provided. FIG. 35A illustrates another embodimentof the invention comprising clamp members 244, 246, wherein the clampmembers 244, 246 are configured with a relative longitudinal motion toprovide the clamping action of the delivery tool. Although theembodiment represented in FIG. 35A depicts a parallel axis arrangementbetween the two distal portions of clamp members 244, 246, in otherembodiments the two clamp members may have a more skewed arrangement.FIG. 35B represents another embodiment where the clamp members 244, 246are configured with a relative longitudinal sliding motion, but unlikethe embodiment of FIG. 35A, clamp member 244 maintains a fixedconfiguration and does not pivot with the opening and closing of thedelivery tool 248. Clamp member 244 also has a U-shaped bend 245 toallow the drill guide to displace farther when it is not in use andclamp member 246 is fitted with an ergonomic handle 247. In stillanother alternative embodiment, one or more of the clamp members may beaxially movable using a threaded rotational interface with the otherclamp members.

Although the embodiments described above are directed to delivery toolshaving two clamp members, it is understood that the scope of theinvention is not limited to these preferred embodiments. In otherembodiments of the invention, three or more clamp members may beprovided in the delivery tool. A multiple clamp member tool may providebetter securement of the hyoid bone and/or hyoid brace during theattachment or drilling procedure, or may provide alternative attachmentorientations for the bone segment that may be more difficult to performwith a dual clamp member delivery tool.

As previously mentioned, a clamp member 202, 204 may further compriseone or more brace retaining structures 220, 222 that are configured toreleasably attach a hyoid brace component. By engaging the bracecomponents during the fixation of the hyoid bone, greater accuracy inattaching the brace component may be achieved through improved alignmentof the hyoid bone, hyoid brace and the drill used to fasten the bracecomponent to the hyoid bone. Referring to a cut-away view in FIG. 36A,one embodiment of the brace retaining structure is a biased clasp 250that can releasably engage a loop or other similar complementarystructure on a hyoid brace component. The clasp 250 may be rotatably orpivotably attached about the distal end 212 of a clamp member 202 at apivot lumen 252 using a pin 254, screw or other fastener. The clasp 250may be biased in one direction by a spring 256 or other bias structureagainst another surface 258 of the clamp member 202 in order to engage aloop or other releasable engagement structure on the hyoid brace. Inthis particular embodiment, surface 258 is the located about the distaltip of clamp member 202. A tab 260 or other release structure on theclasp 250 allows the user to overcome the force exerted by the biasstructure 256 to move the clasp 250 away from the abutting surface 258by pivoting the retaining structure 220 about the pivot pin 254, therebyreleasing the loop structure of the hyoid brace component. FIG. 36Bdepicts one embodiment of the brace retaining structure 220 engaged tothe releasable gripping structure 162 of the hyoid arm 124 depicted inFIG. 27A.

The brace retaining structure on the other clamp member, if any, mayhave the same or a different configuration. In the embodiment of theinvention provided in FIGS. 32A and 32B, the brace retaining structure222 on the clamp member 204 comprises a movable toe grip 262 that may bemanipulated by an actuator 264 to slide the toe grip 262 longitudinallywithin the distal end 214 of the clamp member 204. The toe grip 262 andactuator 264 are depicted in a cut-away view in FIG. 37A. The toe grip262 comprises a pronged structure configured to releasably engageanother structure between the prongs 266. The toe grip 262 has anactuator 264 to allow the operator to slide the toe grip 262 withrespect to the clamp member 204. In this particular embodiment, theposterior screw interface 132 of the hyoid brace component 124 has arecess 268 or narrowed neck which may be engaged by the prongs 266 ofthe toe grip structure 262. To release the engaged hyoid brace component124, the toe grip 262 is pulled away from the recess 268 on the screwinterface 132 of hyoid brace component 124 by the actuator 264. FIG. 37Billustrates the engagement of the toe grip 262 to recess 268 on thescrew interface 132 of the hyoid arm 124 from FIG. 27A.

Although particular examples of the brace retaining structures 220, 222are provided above, one with ordinary skill in the art will understandthat any of a variety of brace retaining structures may be used on theclamp members 202, 204 of the delivery tool 200 and are not restrictedto clasp or toe grip structures.

Optionally, one or both of the distal ends 212, 124 of the clamp members202, 204 may further comprise an alignment surface or structure 270 tomaintain the relative position of the hyoid brace component with respectto one or both of the clamp members 202, 204. An alignment structure 270may relieve some of the mechanical strain on the brace retainingstructures and/or hyoid brace components caused by the manipulation ofthe hyoid bone and hyoid brace during the implantation procedure. FIG.38A depicts one embodiment of the distal end 2-14 of a clamp member 204comprising complementary grooves 272, 274 or depressions configured toalign the connecting members 128 of the hyoid brace component 124depicted in FIGS. 27A. The complementary grooves 272, 274 may also beconfigured to align multiple hyoid brace components. For example, FIG.38B depicts the alignment of brace arm 124 of FIG. 27A in one set ofgrooves 272. The other grooves 274 are configured to align with thecomplementary brace arm 122 of FIG. 27A. In other embodiments of theinvention, however, the brace arms 122, 124 may be configured tointerface the same set of grooves on the clamp member.

In the embodiments of the invention comprising an integral drill guide,a movable drill guide is preferred such that after the drilling of thehyoid bone is completed, the drill guide may be moved away to provideaccess to the drilled hole and to allow fastening of the hyoid bracecomponent without having to unclamp the delivery tool from the hyoidbone. Typically, a movable drill guide comprises a movement range thatincludes positioning the drill guide lumen over a fastener opening orfastener access site on the clamp member having a diameter or crosssectional surface area sufficient to allow a screw head or otherfastener head to pass and attach the hyoid brace component to the hyoidbone. By moving the smaller drill hole guide lumen away from thefastener opening after drilling, interference from the drill guide wheninserting the fastener may be reduced or prevented. Referring to FIGS.39A to 39C, in one embodiment of the invention, the drill guide 224 isconfigured to slide within a slot 278 located on the distal end 212 of aclamp member 202. The slot 278 and the drill guide assembly 224 isconfigured to position the drill guide lumen 280 over the fasteneropening 282. The drill guide assembly 224 may also comprise a drillguide position lock 284 to at least maintain the position of the drillguide assembly 224 during drilling in order to reduce the risk ofimproper drilling or damage to the delivery tool 200 and/or bracecomponents. The drill guide position lock 284 is pivotable andconfigured with a bias toward the clamp member 202 by a spring 288. Thedrill guide position lock 284 and clamp member 202 is configured so thatthe alignment pin 290 on the drill guide position lock 284 forms aninterfit with a complementary alignment structure 292 on the clampmember 202. The drill guide position lock 284 may also he configured tomaintain the position of the drill guide assembly away from the fasteneropening 282 to prevent inadvertent mechanical interference from thedrill guide assembly 224 during the fastening step of the implantationprocess.

In alternative embodiments of the invention, the alignment structure maybe fixed to the slide body and the complementary alignment structure onthe clamp member has a movable bias. One with ordinary skill in the artwill understand that the drill guide assembly may be configured to bemovably attached to the delivery tool in any of a variety of movablerelationships, including a sliding, pivoting, rotating or a combinationthereof.

In still another alternative embodiment of the invention, the drillguide may be used to align self-tapping screws into the hyoid bone suchthat drilling is not required. Referring to FIG. 40, in this embodiment,the drill lumen 280 of the drill guide 224 may be larger in order toaccommodate the body of the screw, and may also have also havelongitudinal separations 294 to separate the drill guide lumen 280 fromthe self-tapping screw once the screw is at least partially engaged thebone.

In further embodiments of the invention, the clamp member opposite theclamp member with the drill guide assembly may comprise a movable drillstop structure which prevents the drill from damaging the hyoid bracestructure on the opposite side of the hyoid bone upon completepenetration of the hyoid bone. The movable drill stop structure mayextend through the posterior or opposing-side structures of the hyoidbrace to contact the drill bit before the drill bit reaches the hyoidbrace structure. When the hyoid brace structure attaches to the hyoidbone and is ready for release from the delivery tool, the, movable drillstop structure may be retracted from the hyoid brace structure tofacilitate its separation from the hyoid brace structure. Referring toFIG. 41A, the drill stop structure 296 may comprise a drill stop pin 298and a drill stop spring 300, the spring 300 comprising a proximal end302 and a distal end 304. In some embodiments, the drill stop structure296 is movable independently from the brace retaining structure, if any,located on the same clamp member. In other embodiments, as depicted inFIG. 41B, the actuator 264 for the brace retaining structure 222 is alsoconfigured to move the drill stop structure to and from of the drillstop position. Referring to FIG. 41C, the proximal end 302 of the spring300 may be attached to the clamp member and the distal end 304 is biasedaway from the clamp member, but can be pushed toward the clamp memberand into the drill stop position by a push structure 306 on the actuator264 as the actuator 264 is moved distally toward the distal end 304 ofthe drill stop spring 296. FIG. 41D illustrates the relationship betweenthe actuator 264 and the toe grip assembly 262 and the drill stopassembly 296. In an alternative embodiment of the invention, the drillstop assembly may be fixed in configuration with respect to the clampmember and separates or pulls away from the hyoid brace component as theclamping members are unclamped from the hyoid bone.

Although the embodiments of the invention described above areadvantageously used in otolaryngology applications, difficult accesssites and/or the small bone remodeling or repair, in other embodimentsof the invention the invention may be adapted for use in orthopedic ortrauma surgeries to improve traditional bone fixation methods involvingthe long bones or other bones such as hip bones. A releasable bonefixation or attachment device on a clamp-like delivery tool mayfacilitate quicker fixation procedures that can reduce operating roomtime and/or patient risk. It is understood that the particularembodiment of the delivery tool described above may be adapted tomanipulate other small bony or calcified anatomical structures or eventhe larger long bones of the body.

In one embodiment of the invention, the patient is prepped and draped inthe usual sterile fashion. The patient is placed under anesthesia andintubated. The patient is then placed in either a supine position orwith the torso bent at any angle from about 0 degrees to about 90degrees. The thyroid notch is palpated and the medial portion of thehyoid bone is accessed using a small incision just above the thyroidnotch. A portion of the hyoid bone is dissected from the surroundingsoft tissue. The hyoid bone is cut into two segments using a sagittalsaw. The first arm of the hyoid brace is attached to the hyoid deliverytool by an anterior clasp and a posterior toe grip. The delivery tooland first arm are then clamped onto opposite sides of the first hyoidbone segment. The movable drill guide on the hyoid delivery tool ismoved and locked into position over the fastener opening of the hyoiddelivery tool. A drill is passed through the drill guide and hyoid boneuntil it contacts the drill stop located on the clamp member about theposterior side of the hyoid bone. The drill is removed and the drillguide is released from its locked position and pushed away from thefastener opening. A screw is inserted into the fastener opening andengaged the first arm of the hyoid brace to the first segment of thehyoid bone. The anterior portion of the first arm of the hyoid brace isthen released from the clasp, and the drill stop is separated from theposterior portion of the first arm of the hyoid brace and the toe gripwith withdrawn proximally to release the firs arm of the hyoid bracefrom the hyoid delivery tool. The steps are repeated to attach thesecond arm of the hyoid brace to the second segment of the hyoid bone.Once the second arm of the hyoid brace is attached, the first arm andsecond arm are fixed to each other using one or more fixation screws.The pharynx is checked for, patency, swelling and bleeding and then thehyoid access site is closed in usual fashion. The patient may or may notbe extubated immediately

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

1-22. (canceled)
 23. A tool for delivering a bone attachment member,comprising: a first clamp member comprising a proximal end, a distalend, a clamping surface and a releasable prosthesis attachment assembly;a second clamp member comprising a proximal end, a distal end and aclamping surface; and a movable drill guide having a drill guide lumendefining a drilling axis and configured to align a drill in asubstantially transverse direction with respect to the clamping surfaceof the first clamp member, the drill guide being movable in a directionperpendicular to the drilling axis without disengagement from the boneattachment member; wherein the first clamp member and second clampmember are attached in a movable relationship having an open positionand a closed position, wherein the clamping surfaces of the first clampmember and the second clamp member have a generally opposing orientationin at least the closed position, wherein the clamping surfaces of thefirst clamp member and the second clamp member are each structured toengage a portion of a bone between the clamping surfaces in the closedposition, and wherein the releasable prosthesis attachment assembly isstructured to releasably and securely attach the bone attachment memberto the first clamp member in both the open position and the closedposition.